colorectal cancer
Conditions
Interventions
Group 1:SOX
Group 2:XELOX
Sponsors
Yixing People's hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent form; 2. aged = 18 years old; 3. Randomly grouped within 2-8 weeks after surgery; 4. Physical condition US Eastern Cancer Cooperative Group (ECOG) score 0-1; 5. Histology: patients diagnosed with stage III colon or rectal adenocarcinoma, or at least one of the following basic characteristics: T4; undifferentiated tumor grade > 3; intestinal obstruction or perforation, vascular, lymphatic or nerve infiltration; 12 nodes; 6. R0 resection.
Exclusion criteria
Exclusion criteria: 1. Metastasis of the primary tumor (including the presence of tumor cells in the ascites or peritoneal metastasis); 2. There are clinically relevant cardiovascular diseases; 3. a history of central nervous system disease, or current evidence confirming a central nervous system disorder; 4. According to the Common Adverse Event Event Evaluation Criteria (CTCAE) v. 3.0 standard, there are 1 or more peripheral neuropathy; 5. Patients who have to undergo radiotherapy after surgery have been evaluated by the investigator; 6. Simultaneous use of targeted therapeutic drugs, such as anti-vascular endothelial growth factor (VEGF) monoclonal antibody, anti-epidermal growth factor receptor (EGFR) monoclonal antibody, etc.; 7. brain metastasis or meningeal metastasis; 8. Insufficient bone marrow reserve capacity, manifested as absolute neutrophil count =1.5×109/L or platelet count =75×109/L, or need regular blood transfusion to maintain hemoglobin =9g/dL; 9. serum bilirubin = 1.5 × upper limit of the reference range (ULRR); 10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 × ULRR. If there is liver metastasis, ALT or AST>5×ULRR; 11. serum creatinine = 1.5 × ULRR or creatinine clearance calculated according to Cockcroft-Gault formula = 50ml / min; 12. evidence of any serious or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, high blood pressure, severe arrhythmia, diabetes, massive active bleeding); 13. Have undergone major surgery within 14 days prior to entering the study, or have a surgical incision that has not fully healed; 14. known to be allergic to oxaliplatin, capecitabine, tigeol or any excipient component of these products; 15. There are other combined anti-cancer treatments (including gonadotropin-releasing hormone agonists, immunotherapy), except for steroid hormones; 16. Have a history of other malignancies in the past 5 years, with the exception of well-treated basal cell carcinoma of the skin and/or cervical carcinoma in situ; 17. A history of significant gastrointestinal damage that the investigator judges may significantly affect Tiegio's absorption, including the ability to swallow the entire drug; 18. There is a known deficiency of dihydropyrimidine dehydrogenase (DPD).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years disease free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 years overall survival;toxicity side;effects safety; | — |
Countries
China
Contacts
Public ContactZhou Yan
Yixing People's hospital
Outcome results
None listed